Understanding of the physiopathological concepts of female stress urinary incontinence (SUI) has consistently improved over the past decades and their application has lead to the development of numerous surgical techniques aimed at curing this disorder. Among these, retro-pubic tension-free vaginal tape (TVT) has probably been the most revolutionary. It has been suggested that retro-pubic TVT may stabilize the mid-urethra at the time of an abdominal pressure increase without modifying cervico-urethral mobility. The use of retro-pubic TVT has been associated with various and relatively frequent per- and post-operative complications, including bladder perforation, temporary or persistent retention, pain, urinary infection, and de novo urgency. Other rare but severe—and possibly underestimated—complications have been reported with this approach. Indeed, the blind passage of the needle in the retro-pubic space can result in injuries to other organs than the bladder, in particular the urethra, vessels, nerves and bowel.
To avoid these complications, alternate approaches with a pre-pubic or transobturator passage of the tape have been developed and continence rates obtained with these routes have been roughly similar to those after the ‘classic’ retro-pubic TVT. In the transobturator technique described by Delorme et al., Prog. Urol., 11: 1306–13, 2001, the tape is inserted through the obturator foramens from outside to inside (in extenso from the thigh folds towards underneath the urethra).
Even though the transobturator outside-in TVT technique is claimed to be a safe procedure, it may occasion urethra and bladder injuries, as reported by Hermieu et al., Prog. Urol, 13: 115–117, 2003.
Distinctions of the Present Invention over the Prior Art
The main differences between the present invention and U.S. Published Pat. Application No. 2002/0099260 relate to:                1. The characteristics of the tape.        2. The operative technique and the surgical instruments employed.        3. The anatomical concepts of the proposed surgery.        4. The physio-pathological aspects of female incontinence.1. The Tape.        
Published patent application No. 2002/0099260 describes a tape made of polypropylene coated in its central region with a substance, such as silicone, which region is intended to be inserted in close vicinity with the urethra and is capable of preventing any adhesion of the surrounding tissues with the tape. The coating of the tape is intended to allow subsequent surgical re-intervention, such as implantation of an artificial sphincter.
One of the objects of the present invention is to restore a fixed bearing-point at the posterior aspect of the urethra, at the border between its middle and inferior thirds. The tape according to the present invention is made, along its entire length, of mono-filament or multi-filament knitted polypropylene. This type of material has been used for several decades for surgical hernia repair, cardiac and vascular surgery, and plastic surgery, for example. This non-absorbable material will be colonized with connective tissue, including fibroblasts, hence allowing the integration of the implant in the tissues. The tape, in the present invention, can be made of synthetic or biological material.
In published patent application No. 2002/0099260, the non-adherent portion of the tape, in its central part, leaves, between the tape and the urethral wall, a space that may favor infection and erosion problems. The literature has described these phenomena of erosion and infection, encountered in 3% of implanted silicone-coated artificial sphincters and, more frequently, when silicone tapes are employed (Duckett, J. R. and Constantine, G.: Complications of silicone sling insertion for stress urinary incontinence., J. Urol. 163(6): 1835–1837, 2000).
2. The Operative Technique and the Surgical Instruments Employed.
According to published Patent application No. 2002/0099260, after a median vaginal wall incision is made at the level of the middle third of the urethra, the lower internal part of each obturator foramen is identified by a finger slipped into the vaginal incision and an incision is made in the groin skin, so as to form an orifice through which an Emmet needle is then passed from outside to inside (in extenso from the groin folds towards underneath the urethra).
Another of the stated objects of the present invention lies in the fact that the design of the invented surgical tools allows the accurate, safe and reproducible placement of the tape from inside to outside (in extenso from underneath the urethra towards the folds of the thighs). The inventive surgical technique of the present invention does not require any marking of the obturator foramens. The original and specific design of the inventive surgical tools of the present invention, which are spiral-shaped with a lag between the initial and terminal ends of the tools, permits to reliably locate, prior to the passage of the needles, their skin exit points at the groin folds. With the inventive tools of the present invention, the exit points are always located above a horizontal line at the level of the urethral meatus line, and one to three centimeters outside the groin folds.
Contrary to the surgical devices of the present invention, EMMET or DOYEN needles are long needles with variable curve angles, but only in one plane. The same EMMET or DOYEN needle is used for passing the tape through both obturator foramens and the operator needs to guide the needle with his fingers, which renders the passage of the needle less accurate and reproducible.
The inventive tools of the present invention are pairs of instruments, specific for each side. The terminal end of the needles is brought into contact with the upper part of the ischio-pubic branches. At this moment, a simple rotation movement, while keeping the handle of the instrument parallel with the sagittal axis of the vulvar slit, allows the precise exit of the needles. Thus, the operative technique described is much safer. The vaginal wall is carefully dissected under visual control. It is impossible to damage the urethra and the bladder since the needles are directly passed from the perineal to the obturator regions, and then to groin folds, running away from the pelvis. Thus a cystoscopy is not necessary.
The passage of the needles described in published patent application No. 2002/0099260 is different, since the needles cross the levator ani muscles, which belong to the pelvic region. With the technique of the needle's passage described in published patent application No. 2002/0099260, a risk of bladder and urethra perforation subsists.
There have been reports of three patients in whom a sub-urethral tape has been inserted according to the method detailed in published patent application No. 2002/0099260 who developed a subsequent urethral fistula. The treatment of the urethral fistula in two of these patients resulted in complete urinary incontinence. In addition, two patients in whom the insertion of a sub-urethral tape according to the method detailed in published patent application No. 2002/0099260 has resulted in the occurrence of a bladder perforation.
3. The Anatomical Concepts of the Proposed Surgery.
In published patent application No. 2002/0099260, it is stated that the tape is passed between the Alban fascia and the peri-urethral fascias. For many authors in the scientific literature, the Alban fascia merely represents a dissection plane and does not correspond to any anatomical structure. At the middle third of the posterior aspect of the urethra, the urethral wall is intimately fused with the anterior wall of the vagina. At that location, no specific aponeurosis exists. In particular, the median perineal aponeuris is always lacking as described by L. Testut in G. Doin, editor, Traité d'Anatomie Humaine, Volume 5, ed. 8, Paris, 1931, pp. 460–461.
4. The Physio-Pathological Aspects of Female Incontinence.
By the present invention the function of the tape is to create a median perineal aponeurosis at the posterior aspect of the urethra and to restore at the middle third of the posterior urethra the fixed bearing point that has been previously reported in the literature by de Leval J., in Acta Urol Belg. 52(1): 147, 1984. At page 32, it is written that “our works have identified a fixed point, which is a genuine pivot of contraction, from which two segments must be distinguished, one superior, and the other inferior. The anatomical correspondence of this point of confluence is the median perineal aponeurosis”.